From the August 2017 issue of HealthCare Business News magazine
By James Laskaris, MD Buyline analyst
Depending on how you cut the pie, servicing and repair of medical equipment in the U.S. is worth more than $14 billion a year.
One ongoing debate is focused on who has the right to service medical technology. Currently, the FDA, the Association for the Advancement of Medical Instrumentation (AAMI) and multiple manufacturers and third-party service organizations, as well as in-house hospital clinical engineering departments, are all actively involved in the discussion of revenue, costs and the effect on patient safety resulting from who services the technology. Even with $14 billion at stake, there is no clear-cut answer.
Years ago, a similar hot topic on the safety of refurbishing single-use medical devices and capital equipment was on the table. This process promised savings of 50 percent or more off the original cost of the device. But OEMs questioned the safety aspects of reprocessed or remanufactured medical devices. The result of this debate was that vendors who refurbished or remanufactured this equipment had to go through the same certification as the OEM.
OEMs have questioned the safety of third-party repair by ISOs and their routine servicing of medical technology. Meanwhile, ISOs and their representative organizations have vehemently cried foul, citing unnecessary regulation and cost increases.
The OEMs and their Medical Imaging Technology Alliance (MITA) have supported passage of the Medical Device Servicing, Safety and Accountability Act, which calls for further regulation of ISOs.
In October 2016, the FDA opened a docket on servicing, and both The Joint Commission and Pennsylvania State University commented that they could find no statistically significant level of safety problems resulting from the activities of any maintenance/service provider.
“This legislation is, however, a solution for a problem which has not been shown to exist,” says the International Association of Medical Equipment Remarketers & Servicers (IAMERS).
IAMERS claims the proposed law would simply add regulation and increase prices.
Supporting the position that third-party service is not associated with patient safety problems is a review conducted of the FDA MAUDE (Manufacturer and User Facility Device Experience) database, which found no evidence that a hazard exists.
However, advocates for greater oversight of third-party equipment stakeholders argue that the MAUDE report research was based on limited data and therefore may not paint a complete picture of the issue.
